Full Thickness Rotator Cuff Tear
Conditions
Brief summary
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
Detailed description
Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.
Interventions
DEVICEBioFiber
Subjects implanted with BioFiber or BioFiber-CM Scaffold
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or older * Patients with full thickness rotator cuff tears (confirmed at time of surgery) that are eligible for rotator cuff repair. * Patients willing and able to comply with the requirements of the study protocol and provide informed consent.
Exclusion criteria
* Patients with active or latent infection * Patients with decreased vascularity * Patients with pathological soft tissue conditions * Patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate * Patients with a known allergy or sensitivity to bovine collagen (BioFiber-CM only) * Participating in a concurrent study that has not been approved for concurrent enrollment by the Clinical Study Manager
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device Associated Adverse Events | 12 Months | The primary objective is to report the number of participants with device associated adverse events. Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Functional Outcome - Adjusted Constant-Murley Score | 6 Months | Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.\[1\] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome. |
| Clinical Functional Outcome - WORC Index | 6 Months | Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life. |
| Number of Study Participants With Re-tears | 6 Months | Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear. |
Countries
France, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BioFiber Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold | 50 |
| BioFiber Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | BioFiber |
|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 6.9 |
| BMI | 27.9 kg/m^2 STANDARD_DEVIATION 7 |
| Region of Enrollment France | 11 participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 50 |
| serious Total, serious adverse events | 3 / 50 |
Outcome results
Primary
Number of Participants With Device Associated Adverse Events
The primary objective is to report the number of participants with device associated adverse events. Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BioFiber | Number of Participants With Device Associated Adverse Events | 4 Participants |
Secondary
Clinical Functional Outcome - Adjusted Constant-Murley Score
Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.\[1\] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.
Time frame: 6 Months
Population: 50 Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioFiber | Clinical Functional Outcome - Adjusted Constant-Murley Score | 93.4 scores on a scale | Standard Deviation 17.5 |
Comparison: Difference from baseline (6M-Baseline)p-value: 0.000195% CI: [25.2, 40]2-sided, paired t-test
Secondary
Clinical Functional Outcome - Adjusted Constant-Murley Score
Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.\[1\] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.
Time frame: 12 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioFiber | Clinical Functional Outcome - Adjusted Constant-Murley Score | 97.1 scores on a scale | Standard Deviation 16.1 |
Comparison: Difference from baseline (12M-Baseline)p-value: 0.000195% CI: [28.7, 42.7]2-sided, paired t-test
Secondary
Clinical Functional Outcome - WORC Index
Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.
Time frame: 6 Months
Population: One subject is missing data for this outcome measure thus a total of 49 subjects were analyzed in this section.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioFiber | Clinical Functional Outcome - WORC Index | 80.7 Percentage of WORC Index | Standard Deviation 18.9 |
Comparison: Difference from baseline (6M-Baseline)p-value: 0.000195% CI: [37.4, 50.1]2-sided, paired t-test
Secondary
Clinical Functional Outcome - WORC Index
Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioFiber | Clinical Functional Outcome - WORC Index | 86.8 Percentage of WORC Index | Standard Deviation 16.3 |
Comparison: Difference from baseline (12M-Baseline)p-value: 0.000195% CI: [43.2, 55.2]2-sided, paired t-test
Secondary
Number of Study Participants With Re-tears
Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BioFiber | Number of Study Participants With Re-tears | 2 Participants |
Secondary
Number of Study Participants With Re-tears
Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BioFiber | Number of Study Participants With Re-tears | 2 Participants |